TCRaß+CD19+ depleted haploidentical stem cell transplantation followed by immunotherapy in patients with relapsed/resistant high-risk neuroblastoma
Key facts
- Where
- Genoa, OlaszországSee the site
- Phase
- 2. fázis
Where in Olaszország
- IRCCS Istituto Giannina GasliniGenoa, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- IRCCS Istituto Giannina Gaslini
- Trial code
- EU 2024-519089-32-02
- Record updated
- 2025. január 31.
- Original description
To evaluate the safety and efficacy of haploidentical stem cell transplantation with alfa-beta-CD19+ depletion folowed by immunotherapy with donor-NK cells infusion and anti-GD2 moAb in patients with high risk Neuroblastoma relapsed or in progression disease after first line treatment.Read full original descriptionShow less
To evaluate the safety and efficacy of haploidentical stem cell transplantation with alfa-beta-CD19+ depletion folowed by immunotherapy with donor-NK cells infusion and anti-GD2 moAb in patients with high risk Neuroblastoma relapsed or in progression disease after first line treatment.
Inclusion: High-risk neuroblastoma (stage 4 with age > 12 months at diagnosis, or stage 2, 3, 4s with MYCN amplification) in local, metastatic or combined recurrence after first-line therapy protocol; Stabilization of disease (at or above STABLE DISEASE according to INRC criteria) achieved after salvage chemotherapy according to the center’s clinical practice; Availability of a suitable HLA haploidentical familial donor to perform HSC donation from peripheral blood after stimulation with GCSF (+/-Plerixafor); Informed parental or legal guardian consent.
Exclusion: Disease progressing after salvage therapy; Severe organ dysfunction, defined as grade 4 or higher dysfunctions according to international reference tables (CTCAE v 5.0); Life expectancy of less than 3 months.